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17 Aug 2021
// BUSINESSWIRE
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-13
Pay. Date : 2012-11-19
DMF Number : 13682
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2002-079 - Rev 09
Issue Date : 2023-05-12
Type : Chemical
Substance Number : 1292
Status : Valid
Registration Number : 303MF10154
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2021-09-28
Latest Date of Registration :
NDC Package Code : 45932-0008
Start Marketing Date : 1998-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20200727-210-J-391(1)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, Kobenhavn S, 2300 Denmark
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2002-226 - Rev 08
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 465
Status : Valid
Registration Number : 225MF10193
Registrant's Address : 108 Binhai Road, Taizhou, Zhejiang 318000 PRC, China
Initial Date of Registration : 2013-10-09
Latest Date of Registration :
NDC Package Code : 45932-0022
Start Marketing Date : 2015-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13363
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2000-207 - Rev 06
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 319
Status : Valid
Registration Number : 221MF10198
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2009-09-14
Latest Date of Registration :
NDC Package Code : 45932-0053
Start Marketing Date : 2020-12-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20200827-210-J-728(1)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, 2300 Kobenhavn S, Denmark
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13536
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1998-061 - Rev 05
Issue Date : 2018-11-21
Type : Chemical
Substance Number : 203
Status : Valid
Registration Number : 219MF10071
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-03-14
Latest Date of Registration :
NDC Package Code : 45932-0002
Start Marketing Date : 1999-06-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2023-08-11
Registration Number : 20210317-211-J-890(A)
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11, 2300 Copenhagen S, Denmark
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 14187
Submission : 1999-06-10
Status : Active
Type : II
Certificate Number : R1-CEP 1998-062 - Rev 06
Issue Date : 2019-04-05
Type : Chemical
Substance Number : 203
Status : Valid
Registration Number : 218MF10934
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2006-11-21
Latest Date of Registration :
NDC Package Code : 45932-0017
Start Marketing Date : 1999-06-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 20210317-211-J-890
Manufacturer Name : Xellia Pharmaceuticals ApS
Manufacturer Address : Dalslandsgade 11 2300 Copenhagen S.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13691
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2007-195 - Rev 03
Issue Date : 2025-04-03
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 219MF10091
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-03-14
Latest Date of Registration :
NDC Package Code : 45932-0050
Start Marketing Date : 2020-06-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (7kg/7kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2023-05-17
Registration Number : 20130604-159-I-162-02(2)
Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd
Manufacturer Address : No.108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-11-15
DMF Number : 13794
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1996-006 - Rev 10
Issue Date : 2019-12-03
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 221MF10171
Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s utca 1-3 Hungary
Initial Date of Registration : 2009-07-30
Latest Date of Registration :
NDC Package Code : 45932-0009
Start Marketing Date : 1998-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Penmix Co., Ltd.
Registration Date : 2016-07-01
Registration Number : 20130604-159-I-162-02(1)
Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd.
Manufacturer Address : No. 108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 20614
Submission : 2007-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 2006-245 - Rev 02
Issue Date : 2019-12-03
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 219MF10216
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-06-25
Latest Date of Registration :
NDC Package Code : 45932-0010
Start Marketing Date : 1998-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Menarini Korea Co., Ltd.
Registration Date : 2013-06-04
Registration Number : 20130604-159-I-162-02
Manufacturer Name : Xellia (Taizhou) Pharmaceuticals Co., Ltd.
Manufacturer Address : No. 108, Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, 318000, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13388
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2002-224 - Rev 08
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 465
Status : Valid
Registration Number : 218MF10935
Registrant's Address : Harbitzalle(´)en 3, P. O. Box 158 Skφyen N-0212 Oslo, Norway
Initial Date of Registration : 2006-11-21
Latest Date of Registration :
NDC Package Code : 44231-0002
Start Marketing Date : 2012-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13494
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2006-132 - Rev 06
Issue Date : 2018-12-18
Type : Chemical
Substance Number : 907
Status : Valid
Registration Number : 218MF10936
Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s u. 3. Hungary
Initial Date of Registration : 2006-11-21
Latest Date of Registration :
NDC Package Code : 61046-0003
Start Marketing Date : 2004-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-13
Pay. Date : 2012-11-19
DMF Number : 13682
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-10-31
DMF Number : 13341
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-17
Pay. Date : 2012-10-31
DMF Number : 13607
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13388
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13608
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2014-06-13
DMF Number : 28355
Submission : 2014-06-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27156
Submission : 2013-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13363
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2012-11-15
DMF Number : 13362
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-01-29
DMF Number : 39378
Submission : 2024-03-27
Status : Active
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2002-079 - Rev 09
Status : Valid
Issue Date : 2023-05-12
Type : Chemical
Substance Number : 1292
CEP/COS
Certificate Numbers : R1-CEP 2002-103 - Rev 10
Status : Valid
Issue Date : 2022-08-18
Type : Chemical
Substance Number : 466
Certificate Numbers : CEP 2002-226 - Rev 08
Status : Valid
Issue Date : 2024-08-22
Type : Chemical
Substance Number : 465
CEP/COS
Certificate Numbers : R1-CEP 2002-224 - Rev 08
Status : Valid
Issue Date : 2018-02-07
Type : Chemical
Substance Number : 465
CEP/COS
Certificate Numbers : R1-CEP 2000-209 - Rev 05
Status : Valid
Issue Date : 2017-07-19
Type : Chemical
Substance Number : 319
CEP/COS
Certificate Numbers : R1-CEP 2000-207 - Rev 06
Status : Valid
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 319
CEP/COS
Certificate Numbers : R1-CEP 2002-241 - Rev 03
Status : Valid
Issue Date : 2018-12-07
Type : Chemical
Substance Number : 320
CEP/COS
Certificate Numbers : R1-CEP 2006-132 - Rev 06
Status : Valid
Issue Date : 2018-12-18
Type : Chemical
Substance Number : 907
CEP/COS
Certificate Numbers : R1-CEP 1998-061 - Rev 05
Status : Valid
Issue Date : 2018-11-21
Type : Chemical
Substance Number : 203
CEP/COS
Certificate Numbers : R1-CEP 1998-062 - Rev 06
Status : Valid
Issue Date : 2019-04-05
Type : Chemical
Substance Number : 203
JDMF
Registration Number : 303MF10154
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2021-09-28
Latest Date of Registration : 2023-10-04
Registration Number : 223MF10046
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2011-03-25
Latest Date of Registration : 2011-03-25
Registration Number : 221MF10198
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2009-09-14
Latest Date of Registration : 2023-10-04
JDMF
Registration Number : 228MF10078
Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s u. 3. Hungary
Initial Date of Registration : 2016-03-29
Latest Date of Registration : 2016-03-29
JDMF
Registration Number : 218MF10936
Registrant's Address : H-1107 Budapest, Sza(´)lla(´)s u. 3. Hungary
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Registration Number : 219MF10325
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-10-24
Latest Date of Registration : 2012-02-09
Registration Number : 225MF10193
Registrant's Address : 108 Binhai Road, Taizhou, Zhejiang 318000 PRC, China
Initial Date of Registration : 2013-10-09
Latest Date of Registration : 2013-10-09
Registration Number : 218MF10935
Registrant's Address : Harbitzalle(´)en 3, P. O. Box 158 Skφyen N-0212 Oslo, Norway
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Registration Number : 218MF10934
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
Registration Number : 219MF10071
Registrant's Address : Dalslandsgade 11, DK-2300 Copenhagen-S, Denmark
Initial Date of Registration : 2007-03-14
Latest Date of Registration : 2007-03-14
Excipients
Inspections and registrations
ABOUT THIS PAGE
Xellia Pharmaceuticals ApS is a supplier offers 27 products (APIs, Excipients or Intermediates).
Find a price of Amphotericin B bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Bacitracin Zinc bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Colistimethate Sodium bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Polymyxin B Sulfate bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Vancomycin Hydrochloride bulk with DMF, CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Bacitracin Zinc bulk with CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Gramicidin bulk with CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Bacitracin Zinc bulk with DMF, CEP offered by Xellia Pharmaceuticals ApS
Find a price of Colistimethate Sodium bulk with CEP, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Colistin Sulfate bulk with DMF, CEP offered by Xellia Pharmaceuticals ApS
Find a price of Daptomycin bulk with DMF, JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Tobramycin Sulfate bulk with JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Amphotericin B bulk with JDMF offered by Xellia Pharmaceuticals ApS
Find a price of Bacitracin Zinc bulk with DMF offered by Xellia Pharmaceuticals ApS
Find a price of Dalbavancin bulk with DMF offered by Xellia Pharmaceuticals ApS
Find a price of Gramicidin bulk with DMF offered by Xellia Pharmaceuticals ApS
Find a price of Tobramycin bulk with DMF offered by Xellia Pharmaceuticals ApS
Find a price of Tyrothricin bulk with CEP offered by Xellia Pharmaceuticals ApS
Find a price of Vancomycin Hydrochloride bulk with DMF offered by Xellia Pharmaceuticals ApS
Find a price of Caspofungin bulk offered by Xellia Pharmaceuticals ApS
Find a price of Mupirocin bulk offered by Xellia Pharmaceuticals ApS
Find a price of Bacitracin Zinc bulk offered by Xellia Pharmaceuticals ApS
Find a price of Colistimethate Sodium bulk offered by Xellia Pharmaceuticals ApS
Find a price of Fluticasone Propionate bulk offered by Xellia Pharmaceuticals ApS
Find a price of Mometasone Furoate bulk offered by Xellia Pharmaceuticals ApS
Find a price of Polymyxin B Sulfate bulk offered by Xellia Pharmaceuticals ApS
Find a price of Tobramycin Sulfate bulk offered by Xellia Pharmaceuticals ApS